Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients (CIN-RG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by PLC Medical Systems, Inc.
Sponsor:
Information provided by (Responsible Party):
PLC Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01456013
First received: October 18, 2011
Last updated: February 27, 2014
Last verified: February 2014

October 18, 2011
February 27, 2014
January 2012
Not Provided
Incidence of Contrast Induced Nephropathy [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01456013 on ClinicalTrials.gov Archive Site
  • Major Adverse Cardiac Events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Mean peak increase in serum creatinine post contrast administration [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Proportion of patients who develop CIN at 7 days post contrast administration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Proportion of patients who maintain a rise in serum creatinine at 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients
A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared With Standard Care in the Prevention of Contrast Induced NephRopathy in the SettinG of a Catheterization Laboratory

Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contrast Induced Nephropathy
  • Device: RenalGuard Therapy
    Induced Diuresis with matched replacement
  • Drug: Standard Therapy
    Standard of care for patients at risk of CIN
  • Active Comparator: Standard Therapy
    Standard of care for patients at risk of CIN
    Intervention: Drug: Standard Therapy
  • Experimental: RenalGuard Therapy
    Induced Diuresis with Matched Replacement
    Intervention: Device: RenalGuard Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
326
Not Provided
Not Provided

Inclusion Criteria:

  • Male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
  • Subject is scheduled to undergo an elective catheterization procedure
  • Hemodynamically stable
  • At increased risk of developing CIN
  • Subject has agreed to all follow-up testing.

Exclusion Criteria:

  • Class 3 or 4 Congestive Heart Failure (CHF)
  • Is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a Foley catheter placed.
  • Subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
  • Has documented severe Aortic Stenosis.(Note: Subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
  • Currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
  • Patient has moderate to severe anemia (hematocrit < 27%) at screening
  • Has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the7 day follow-up period.
  • Has ruled in for an Serious Heart Attack within 48 hours of the planned procedure
  • Has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
  • Planned addition, discontinuation or dose adjustment of the nephrotoxic drugs
  • Subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
  • Subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
  • Subject is pregnant or breastfeeding.
  • Subject is unable to provide informed consent.
Both
18 Years and older
No
Contact: Andrew Halpert 508-541-8800 ahalpert@plcmed.com
United States
 
NCT01456013
RGS001D
Yes
PLC Medical Systems, Inc.
PLC Medical Systems, Inc.
Not Provided
Principal Investigator: Charles Davidson, MD Northwestern University
Principal Investigator: Richard Solomon, MD University of Vermont
Principal Investigator: Roxana Mehran, MD Mount Sinai School of Medicine
PLC Medical Systems, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP